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510(k) K823745

Device
Advance Emit-aed Ethosuximide
Applicant
SYVA CO.
510(k) number
K823745
Product code
DLF
Decision
Substantially Equivalent (SESE)
Decision date
1983-01-07
Date received
1982-12-13
Regulation
862.3380
Classification name
Enzyme Immunoassay, Ethosuximide
Medical specialty
Clinical Toxicology
Review panel
Clinical Toxicology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code DLF#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K881607EASY-TEST EMIT(R) ETHOSUXIMIDE (ETHS) ITEM 16647Em Diagnostic Systems, Inc.1988-06-01
K850174TDX ETHOSUXIMIDEAbbott Laboratories1985-02-06
K844204EMIT QST ETHOSUXIMIDE ASSAYSyva Co.1984-12-11
K832797MODIFICA- OF EMIT AED ETHOSUXIMIDE ASSAYSyva Co.1983-09-29
K823801AMES TDA ETHOSUXIMIDE TESTMiles Laboratories, Inc.1983-01-14
K792584ACA ETHOSURIMIDE TEST PACKE.I. Dupont DE Nemours & Co., Inc.1979-12-31
K780380ANALYZER, FAST, CENTRIFUGAL, GEMSAECSyva Co.1978-04-12
K780461ANALYZER-SUPPLEMENT, KINETIC, LKB 2086Syva Co.1978-04-12